ACMG Public Policy Activities

ACMG is a strong advocate for its members—the professionals who comprise the genetic and genomic healthcare communities. By advocating for issues of highest priority to sustain our field and promote the ACMG’s core values and mission, we also improve the lives and health of the families with and at risk for heritable disorders, whom we serve.

Advocacy joins Clinical and Laboratory Practice, and Education, as one of the three pillars in ACMG’s 2015 Strategic Plan, which charges us to “work with policymakers and payers to support the responsible application of genomics in medical practice”. 

Listed below are national policy issues in which ACMG has been active. Under each issue are the policy documents ACMG has developed and/or to which it has responded. These include providing written public comments to proposed federal legislation, agency guidance and proposed rules; giving testimony before Congress; as well as lending technical assistance in crafting legislative and regulatory documents.

Issue Areas

Access to Affordable, High-Quality Health Care Coverage and Services 
CMSS Letter to US Senate and House of Representatives (2017)

Impact of US Immigration Ban on Healthcare Delivery System

CMSS Sign-On Letter to President Trump and US House of Representatives (2017)

Intellectual Property

Patent Primer (2003)
Points to Consider in Preparing License Agreements for Patented Genetic Tests (2004)

Medical Foods

AMA Resolution-Health Coverage for Nutritional Products for Inborn Errors of Metabolism D-185.982 (2016)
Medical Foods for Inborn Errors of Metabolism: Issues in Patient Access (historical perspective presented to the ACHDNC, May 9, 2016) (2016)
HR 2587, Medical Nutrition Equity Act of 2017 (US House of Representatives(May 2017) 
S1194, Medical Nutrition Equity Act of 2017 (US Senate) (May 2017)

Next Generation Sequencing

FDA Public Meeting on Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests (2016)

Payment Policy

Response to Cytogenetic Microarray Coverage Under Medicare (2013)
MoPath Rate Setting Webinar (2013)
Palmetto Molecular Diagnostics Services Program (2013)

Prenatal Screening and Testing Education 

H.R. 114-3441, Accurate Education for Prenatal Screenings Act (2015)
Letter of Support for H.R. 114-3441 (2015)
House Energy and Commerce Committee Hearing Memo, H.R. 114-3441 (2015)
ACMG Testimony of Anthony Gregg MD FACMG on H.R. 114-3441 (2015)

Privacy of Genetic Information

EEOC's Proposed Changes to the Americans with Disabilities Act Regarding Wellness Program (2015)
Response to the Proposed Rule Making to Revise the Common Rule (2016)
Comments on EEOC's Proposed Rule for Tittle II of GINA (2016)
Sign-On Letter re: H.R.1313 on the Use of Genetic Information in Employee Wellness Programs (2017)

Regulation of Laboratory Developed Tests (LDTs)

FDA Laboratory Developed Tests (LDTs) Responses (2015)
Follow-Up to ACMG/AMP Webinar, "Impending Actions on Laboratory Developed Tests (LDTs) (2016)
ACMG/AMP/ISDA Congressional Briefing on Laboratory Developed Tests (2016)

Value of Genetics
Developing a Value Framework for Genetic Diagnosis: A Systematic Review of Outcomes Hierarchies and Measurement Approaches (2012)